††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS
211.844 requires the Cabinet for Health and Family Services to promulgate
administrative regulations concerning the possession or use of sources of
ionizing or electronic product radiation and the handling and disposal of
radioactive waste. KRS 194A.050 authorizes the secretary to promulgate
administrative regulations necessary to implement programs mandated by federal
law or to qualify for the receipt of federal funds and necessary to cooperate
with other state and federal agencies for the proper administration of the
cabinet and its programs. This administrative regulation establishes requirements
for issuing specific licenses to persons who manufacture, assemble, repair, or
distribute commodities, products, or devices, that contain radioactive material.

††††† Section 1. Registration of Product
Information. (1) A manufacturer or initial distributor of a sealed source, or
device containing a sealed source, whose product is intended for use under a
specific license, shall submit a request to the cabinet pursuant to 10 C.F.R.
32.210, for evaluation of radiation safety information about its product and
for its registration.

††††† (2) The request for review of a sealed
source or device shall include sufficient information to provide reasonable
assurance that the radiation safety properties of the source or device are adequate
to protect health and minimize danger to life and property.

††††† (3) The request shall include information
on:

††††† (a) Design;

††††† (b) Manufacture;

††††† (c) Prototype testing;

††††† (d) Quality control program;

††††† (e) Labeling;

††††† (f) Proposed uses; and

††††† (g) Leak testing.

††††† (4) For a device, the request shall also
include sufficient information about:

††††† (a) Installation;

††††† (b) Service and maintenance;

††††† (c) Operating and safety instructions;
and

††††† (d) Potential hazards.

††††† (5) The cabinet shall evaluate a sealed
source or device using radiation safety criteria in accepted industry
standards. If the standards and criteria pursuant to 10 C.F.R. 32.210, do not
readily apply to a particular case, the cabinet shall formulate reasonable standards
and criteria, with the help of the manufacturer or distributor. The cabinet
shall use criteria and standards sufficient to ensure that the radiation safety
properties of the device or sealed source are adequate to protect health and
minimize danger to life and property.

††††† (6) After completion of the evaluation,
the cabinet shall issue a certificate of registration to the person making the
request. The certificate shall acknowledge the availability of the submitted
information for inclusion in an application for a specific license proposing
use of the product.

††††† (7) A person submitting the request for
evaluation and registration of safety information about the product shall
manufacture and distribute the product in accordance with:

††††† (a) The statements and representations,
including quality control program, contained in the request; and

††††† (b) The provisions of the registration
certificate.

††††† Section 2. Licensing the Introduction of
Radioactive Material into Products in Exempt Concentrations. (1) In addition to
the requirements established in 902 KAR Chapter 100 a specific license authorizing
the introduction of radioactive material into a product or material owned by or
in the possession of the licensee or another, to be transferred to a person
exempt under 902 KAR 100:045, Section 2(1)(a) shall be issued if:

††††† (a) The applicant submits a description
of the:

††††† 1. Product or material into which the
radioactive material will be introduced;

††††† 2. Intended use of the radioactive
material and the product or material into which it is introduced;

††††† 3. Method of introduction;

††††† 4. Initial concentration of the
radioactive material in the product or material;

††††† 5. Control methods to assure that no more
than the specified concentration shall be introduced into the product or
material;

††††† 6. Estimated time interval between
introduction and transfer of the product or material; and

††††† 7. Estimated concentrations of the radioactive
material in the product or material at the time of transfer; and

††††† (b) The applicant provides reasonable assurance
that the:

††††† 1. Concentrations of the radioactive
material at the time of transfer shall not exceed the concentrations
established in 902 KAR 100:085;

††††† 2. Reconcentration of the radioactive
material in concentrations exceeding those in 902 KAR 100:085 is not likely;

††††† 3. Use of lower concentrations is not feasible;
and

††††† 4. Product or material is not likely to
be incorporated in a food, beverage, cosmetic, drug, or other commodity or
product designed for ingestion or inhalation by, or application to, a human
being.

††††† (b) File an annual report with the
cabinet that shall include the:

††††† 1. Type and quantity of a product or
material into which radioactive material has been introduced during the
reporting period;

††††† 2. Name and address of the person who
owned or possessed the product or material into which radioactive material has
been introduced at introduction;

††††† 3. Type and quantity of radionuclide introduced
into a product or material; and

††††† 4. Initial concentrations of the
radionuclide in the product or material at transfer of the radioactive material
by the licensee;

††††† (c) Indicate in the report if no
transfers of radioactive material have been made during the reporting period;

††††† (d) File a report by July 30 covering the
year ending the previous June 30; and

††††† (e) Maintain the record of a transfer for
a period of one (1) year after the event is included in a report to the
cabinet.

††††† Section 3. Resins Containing Scandium-46
and Designed for Sand-Consolidation in Oil Wells: Requirements for License to
Manufacture or Initially Transfer for Sale or Distribution. An application for
a specific license to manufacture or initially transfer for sale or distribution,
synthetic plastic resins containing scandium-46 for use as indicated in 902 KAR
100:045, Section 3(3), shall be approved if:

††††† (2) The product is designed to be used only
for sand-consolidation in oil wells;

††††† (3) The applicant submits the following information:

††††† (a) A general description of the product
to be manufactured or initially transferred; and

††††† (b) A description of control procedures
used to assure that the concentration of scandium-46 in the final product at
the time of distribution shall not exceed 1.4x10-3 micro-curie/milliliter;
and

††††† (4) A container of the product bears a
durable, legible label approved by the cabinet based on the following information:

††††† (a) The product name;

††††† (b) A statement that the product contains
radioactive scandium and is designed and manufactured only for
sand-consolidation in oil wells;

††††† (c) Instructions necessary for proper
use; and

††††† (d) The manufacturer's name.

††††† Section 4. Licensing the Manufacture and
Distribution of a Device to a Person Generally Licensed under 902 KAR 100:050.
(1) In addition to the requirements established in 902 KAR Chapter 100 an
application for a specific license to distribute certain devices containing
radioactive material, excluding special nuclear material, to a person generally
licensed shall be issued only if the applicant submits sufficient information
relating to the:

††††† 1. Under accident conditions, such as
fire and explosion associated with handling, storage, and use of the device, it
is unlikely that a person would receive an external radiation dose or dose
commitment in excess of the following organ doses:

††††† b. Hands and forearms, feet and ankles,
or localized areas of skin averaged over areas no larger than one (1) square
centimeter - 200 rems (2 Sv); or

††††† c. Other organs - 50 rems (500 mSv);

††††† 2. Under ordinary conditions of handling,
storage, and use of the device, the radioactive material contained in the
device shall not be released or inadvertently removed from the device, and it
is unlikely that a person will receive in a period of one (1) calendar year a
dose in excess of ten (10) percent of the limits specified in 902 KAR 100:019,
Section 3; and

††††† 3. The device can be safely operated by individuals
not having training in radiological protection.

††††† (2) A device identified in subsection (1)
of this section shall bear a durable, legible, clearly visible label or labels,
in accordance with 902 KAR 100:050, which contain in a clearly identified and
separate statement:

††††† (a) Instructions and precautions
necessary to assure safe installation, operation, and servicing of the device or
reference to documents, such as operating and service manuals identified in the
label that are used to provide this information;

††††† (b) The requirement, or lack of requirement,
for leak testing or for testing an "on-off" mechanism and indicator,
including the maximum time interval for the testing and the identification of
radioactive material by:

††††† 1. Isotope;

††††† 2. Quantity of radioactivity; and

††††† 3. Date of determination of the quantity;
and

††††† (c) The information called for in the
following statement, in the same or substantially similar form:

††††† "The receipt, possession, use, and
transfer of this device, Model _______, Serial No. __________, are subject to a
general license or the equivalent and the regulations of the U.S. Nuclear
Regulatory Commission or an Agreement State. This label shall be maintained on
the device in a legible condition. Removal of this label is prohibited.

CAUTION - RADIOACTIVE MATERIAL

Name of manufacturer or distributor

The model, serial number, and name of the
manufacturer or distributor may be omitted from this label if the information
is elsewhere specified in labeling affixed to the device.

††††† (3)(a) If the applicant desires that the
device identified in subsection (1) of this section be required to be tested
for proper operation of the "on-off" mechanism and indicator or for
leakage of radioactive material, subsequent to the initial tests required by this
administrative regulation at intervals longer than six (6) months but not
exceeding three (3) years, the applicant shall include in the application
sufficient information to demonstrate that the longer interval is justified by:

††††† 1. Performance characteristics of the
device or similar devices; and

††††† 2. Design features that have a
significant bearing on the probability or consequences of leakage of
radioactive material from the device or failure of the "on-off"
mechanism and indicator.

††††† (b) In determining the acceptable
interval for the test for leakage of radioactive material, the cabinet may
consider information that shall include:

††††† 1. Primary containment or source capsule;

††††† 2. Protection of primary containment;

††††† 3. Method of sealing containment;

††††† 4. Containment construction materials;

††††† 5. Form of contained radioactive
material;

††††† 6. Maximum temperature withstood during
prototype tests;

††††† 7. Maximum pressure withstood during
prototype tests;

††††† 8. Maximum quantity of contained radioactive
material;

††††† 9. Radiotoxicity of contained radioactive
material; and

††††† 10. Operating experience with identical
devices or similarly designed and constructed devices.

††††† (4)(a) If the applicant desires
authorization of the general licensee established in 902 KAR 100:050, Section
3, or pursuant to equivalent regulations of the U.S. Nuclear Regulatory
Commission or an Agreement State, to install the device, collect the sample to
be analyzed by a specific licensee for leakage of radioactive material, service
the device, test the "on-off" mechanism and indicator, or remove the
device from installation, the applicant shall include in the application:

††††† 1. Written instructions to be followed by
the general licensee;

††††† 2. Estimated calendar quarter doses associated
with the activity or activities; and

††††† 3. Basis for the estimates.

††††† (b) The information shall demonstrate
that performance of the activity by an individual untrained in radiological
protection, handling, storage, and use of devices under the general license, is
unlikely to cause that individual to receive a dose in excess of ten (10) percent
of the annual limits specified in 902 KAR 100:019, Section 3.

††††† (a) Furnish a copy of the general license
identified in 902 KAR 100:050, Section 3, to each person to whom the licensee,
directly or through an intermediate person, transfers radioactive material in a
device for use as authorized by a general license;

††††† (b) Furnish a copy of the general license
contained in the U.S. Nuclear Regulatory Commission's or Agreement State's
regulation equivalent to 902 KAR 100:050, Section 3, or alternatively, furnish
a copy of the general license to each person to whom the licensee directly or
through an intermediate person transfers radioactive material in a device for
use pursuant to the general license of the U.S. Nuclear Regulatory Commission
or the Agreement State. If a copy of the general license identified in 902 KAR
100:050, Section 3, is furnished to the person, it shall be accompanied by a
note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory
Commission or Agreement State under requirements substantially the same as
those in 902 KAR 100:050, Section 3;

††††† (c) Report to the cabinet transfers of
the devices to persons for use under the general license.

††††† 1. The report shall identify:

††††† a. A general licensee by name and address;

††††† b. An individual by name or position who
may constitute a point of contact between the cabinet and the general licensee;

††††† c. The type and model number of device
transferred; and

††††† d. The quantity and type of radioactive material
contained in the device.

††††† 2. If one (1) or more intermediate
persons possess the device temporarily at the intended place of use prior to
its possession by the user, the report shall include identification of each
intermediate person by name, address, contact, and relationship to the intended
user.

††††† 3. The report shall indicate if no
transfers have been made to persons generally licensed during the reporting
period.

††††† 4. The report shall cover a calendar quarter
and shall be filed within thirty (30) days of the close of the quarter.

††††† (d) Furnish reports to other agencies,
including:

††††† 1.a. Report to the U.S. Nuclear
Regulatory Commission transfers of these devices to persons for use under the
U.S. Nuclear Regulatory Commission general license in Section 31.5 of 10 C.F.R.
Part 31; or

††††† b. Report to the responsible state agency
transfers of devices manufactured and distributed for use under a general
license in that state's regulations equivalent to 902 KAR 100:050, Section 3;

††††† c. Identify:

††††† (i) A general licensee by name and address;

††††† (ii) An individual by name or position
who may constitute a point of contact between the agency and the general
licensee;

††††† (iii) The type and model of the device
transferred; and

††††† (iv) The quantity and type of radioactive
material contained in the device;

††††† 2. If one (1) or more intermediate
persons possess the device temporarily at the intended place of use prior to
its possession by the user, include identification of each intermediate person
by name, address, contact, and relationship to the intended user;

††††† 3. Submit within thirty (30) days after
the end of the calendar quarter in which the device is transferred to the
generally licensed person;

††††† 4. If no transfers have been made to U.S.
Nuclear Regulatory Commission licensees during the reporting period, this
information shall be reported to the U.S. Nuclear Regulatory Commission; and

††††† 5. If no transfers have been made to general
licensees within a particular state during the reporting period, this
information shall be reported to the responsible state agency upon request of
that agency;

††††† (e) Keep records showing the name,
address, and the point of contact for a general licensee to which the licensee,
directly or through an intermediate person, transfers radioactive material in
devices for use as authorized by a general license or equivalent regulations of
the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall
show:

††††† 1. The date of transfer;

††††† 2. The radionuclide and the quantity of
radioactivity in each device transferred;

††††† 3. The identity of the intermediate
person; and

††††† 4. Compliance with the report requirements;
and

††††† (f) Maintain the records required by paragraphs
(c) and (d) of this subsection for a period of five (5) years from the date of
the recorded transfer.

††††† Section 5. Special Requirements for the
Manufacture, Assembly, or Repair of Luminous Safety Devices for use in
Aircraft. An application for a specific license to manufacture, assemble, or
repair luminous safety devices containing tritium or promethium-147 for use in
aircraft, for distribution to persons generally licensed pursuant to 902 KAR
100:050, shall be approved if:

††††† Section 8. Manufacture and Distribution
of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing
under a General License. An application for a specific license to manufacture
or distribute radioactive material for use pursuant to the general license established
in 902 KAR 100:050, Section 4, shall be approved if:

††††† (b) Displaying the radiation caution
symbol described in 902 KAR 100:019, Section 23, and the words, "Caution,
Radioactive Material" and "Not for Internal or External Use in Humans
or Animals";

††††† (4) The following statement, or a
substantially similar statement which contains the information called for in
the following statement, appears on a label affixed to a prepackaged unit, or
appears in a leaflet or brochure which accompanies the package:

††††† "This radioactive material may be
received, acquired, possessed, and used only by physicians, veterinarians,
clinical laboratories or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use, and transfer are subject to the administrative regulations and
a general license or the equivalent of the United States Nuclear Commission or
of an Agreement State.

(Name of Manufacturer)"; and

††††† (5) The label affixed to the unit, or the
leaflet or brochure that accompanies the package, contains adequate information
regarding precautions to be observed in handling and storing the radioactive material.
For a mock iodine-125 reference or calibration source, the information
accompanying the source shall contain directions to the licensee regarding the
waste disposal requirements established in 902 KAR 100:021, Section 1.

††††† Section 9. Manufacture and Distribution
of Radiopharmaceuticals Containing Radioactive Material for Medical Use Under
Specific Licenses. (1) An application for a specific license to manufacture, prepare,
or transfer for commercial distribution radiopharmaceuticals containing
radioactive material for use by persons licensed pursuant to 902 KAR 100:072,
shall be approved if the applicant:

††††† (b) Submits evidence that the applicant
is at least one (1) of the following:

††††† 1. Registered or licensed with the U.S.
Food and Drug Administration (FDA) as a drug manufacturer;

††††† 2. Registered or licensed with a state
agency as a drug manufacturer;

††††† 3. Licensed as a pharmacy by the State
Board of Pharmacy; or

††††† 4. Operating as a nuclear pharmacy within
the federal medical institution;

††††† (c) Submits information on:

††††† 1. The radionuclide;

††††† 2. Chemical and physical form;

††††† 3. Maximum activity per vial, syringe,
generator, or other container of the radioactive drug; and

††††† 4. Shielding provided by the packaging of
the radioactive material to show it is appropriate for safe handling and
storage of radiopharmaceuticals by medical use licensees; and

††††† (d) Satisfies the labeling requirements
in this paragraph:

††††† 1. The label shall be affixed to the
transport radiation shield, if it is constructed of lead, glass, plastic, or
other material of a radioactive drug to be transferred for commercial
distribution. The label shall include:

††††† c. An identifier that ensures the
syringe, vial, or other container can be correlated with the information on the
transport radiation shield label.

††††† (2) A licensee described by subsection
(1)(b)3 or 4 of this section may:

††††† (a) Prepare radioactive drugs for medical
use, as defined in 902 KAR 100:010, if the radioactive drug is prepared by an
authorized nuclear pharmacist, as specified in paragraphs (b) and (c) of this
subsection, or an individual under the supervision of an authorized nuclear
pharmacist, as specified in 902 KAR 100:072, Section 12;

††††† (b) Allow a pharmacist to work as an
authorized nuclear pharmacist if the individual:

††††† 2. Meets the requirements specified in
902 KAR 100:072, Sections 63 and 66, and the licensee has received an approved
license amendment identifying the individual as an authorized nuclear pharmacist;
or

††††† 3. Is designated as an authorized nuclear
pharmacist in accordance with paragraph (c) of this subsection; and

††††† (c) Designate a pharmacist as an
authorized nuclear pharmacist if the individual is identified as an authorized
user on a nuclear pharmacy license issued by the cabinet.

††††† (3) The actions authorized in subsections
(2)(a) and (b) of this section shall be permitted in spite of more restrictive
language in license conditions.

††††† (4) A licensee shall provide to the
cabinet a copy of an individualís certification by the Board of Pharmaceutical
Specialties, the cabinet, the U.S. Nuclear Regulatory Commission, or an
agreement state license, and a copy of the state pharmacy licensure or registration,
no later than thirty (30) days after the date that the licensee allows the
individual to work as an authorized nuclear pharmacist, pursuant to subsection
(2)(b)1 and 3 of this section.

††††† (5) A licensee shall:

††††† (a) Possess and use instrumentation to
measure the radioactivity of radioactive drugs;

††††† (b) Have procedures for use of the
instrumentation;

††††† (c) Measure, by direct measurement or by
combination of measurements and calculations, the amount of radioactivity in dosages
of alpha-, beta- or photon-emitting radioactive drugs prior to transfer for
commercial distribution;

††††† (d) Perform accuracy, linearity, and
geometry dependence tests on an instrument before initial use, periodically,
and following repair, as appropriate for the instrument, and make necessary
adjustments; and

††††† (e) Check an instrument for constancy and
proper operation at the beginning of each day of use.

††††† (6) This section shall not relieve a licensee
from complying with applicable FDA, other federal, and state requirements governing
radioactive drugs.

††††† Section 10. Manufacture and Distribution
of Sources or Devices Containing Radioactive Material for Medical Use. An
application for a specific license to manufacture and distribute sources and
devices containing radioactive material to persons licensed as authorized by
902 KAR 100:072 for use as a calibration, transmission, or reference source or
for medical uses listed in 902 KAR 100:072, Sections 37, 45 and 46 shall be
approved if:

††††† (e) Details of quality control procedures
to assure that production sources and devices meet the standards of the design
and prototype tests;

††††† (f) Procedures and standards for
calibrating sources and devices;

††††† (g) Legend and methods for labeling
sources and devices as to their radioactive content; and

††††† (h) Instructions for handling and storing
the source or device from the radiation safety standpoint. The instructions
shall be included on a durable label attached to the source or device, or attached
to a permanent storage container for the source or device. Instructions too
lengthy for a label may be summarized on the label and printed in detail on a
brochure referenced on the label;

††††† (3) The label affixed to the source or
device, or to the permanent storage container for the source or device,
contains:

††††† (a) Information on the radionuclide;

††††† (b) Quantity and date of assay; and

††††† (c) A statement that the name of source
or device is licensed by the cabinet for distribution to persons licensed as
authorized by 902 KAR 100:072, or under equivalent licenses of the U.S. Nuclear
Regulatory Commission or an Agreement State;

††††† (4) If an applicant desires the source or
device to be tested for leakage of radioactive material at intervals longer
than six (6) months, the applicant shall include in the application sufficient
information to demonstrate that the longer interval is justified by:

††††† (a) Performance characteristics of the
source or device, or similar sources or devices; and

††††† (b) Design features having a significant
bearing on the probability or consequence of leakage of radioactive material
from the source; and

††††† (5) In determining the acceptable
interval for tests of leakage of radioactive material, the cabinet shall
consider information that includes:

††††† (a) Primary containment or source
capsule;

††††† (b) Protection of primary containment;

††††† (c) Method of sealing containment;

††††† (d) Containment construction materials;

††††† (e) Form of contained radioactive
material;

††††† (f) Maximum temperature withstood during
prototype tests;

††††† (g) Maximum pressure withstood during
prototype tests;

††††† (h) Maximum quantity of contained
radioactive material;

††††† (i) Radiotoxicity of contained
radioactive material; and

††††† (j) Operating experience with identical
sources or devices, or similarly designed and constructed sources or devices.

††††† Section 11. Requirements for License to
Manufacture and Distribute Industrial Products Containing Depleted Uranium for
Mass-volume Applications. (1) An application for a specific license to manufacture
or distribute an industrial product or device containing depleted uranium for
use authorized by 902 KAR 100:050, Section 2, or equivalent regulations of the
U.S. Nuclear Regulatory Commission or an Agreement State shall be approved if:

††††† (c) The applicant provides reasonable
assurance that possession, use, or transfer of the depleted uranium in the
product or device is not likely to cause an individual to receive in a period
of one (1) year a radiation dose in excess of ten (10) percent of the limits
specified in 902 KAR 100:019, Section 3; and

††††† (d) The applicant submits sufficient
information regarding the industrial product or device, and the presence of
depleted uranium for a mass-volume application in the product or device, to
provide reasonable assurance that unique benefits will accrue to the public
because of the usefulness of the product or device.

††††† (2) For an industrial product or device that
has questionable unique benefits, the cabinet may approve an application for a
specific license pursuant to this section only if the product or device is
found to combine a high degree of utility and low probability of uncontrolled
disposal and dispersal of significant quantities of depleted uranium into the
environment.

††††† (3) The cabinet shall deny an application
for a specific license pursuant to this section if the end use of the
industrial product or device cannot reasonably be foreseen.

††††† (4) A person licensed as authorized by
this section shall:

††††† (a) Maintain the level of quality control
required by the license in:

††††† 1. Manufacture of the industrial product
or device; and

††††† 2. Installation of the depleted uranium
into the product or device;

††††† (b) Label or mark each unit to identify:

††††† 1. The manufacturer of the product or
device;

††††† 2. The number of the license under which
the product or device was manufactured or distributed;

††††† 3. The fact that the product or device
contains depleted uranium;

††††† 4. The quantity of depleted uranium in
the product or device; and

††††† 5. That the receipt, possession, use, or
transfer of the product or device is subject to a general license, or the equivalent,
and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement
State;

††††† (c) Assure that the depleted uranium,
before being installed in a product or device, has been impressed with the
legend "DEPLETED URANIUM" clearly legible through plating or other
covering;

††††† (d) Furnish a copy of the general license
contained in:

††††† 1. 902 KAR 100:050 to a person to whom
depleted uranium is transferred in a product or device for use authorized by
the general license; or

††††† 2. The U.S. Nuclear Regulatory
Commission's or Agreement State's regulation equivalent to 902 KAR 100:050, and
a copy of an applicable U.S. Nuclear Regulatory Commission's or Agreement
State's certificate, to a person to whom depleted uranium is transferred in a
product or device for use as authorized by the general license of the U.S.
Nuclear Regulatory Commission or an Agreement State, with a note explaining
that use of the product or device is regulated by the U.S. Nuclear Regulatory
Commission or an Agreement State under requirements substantially the same as
those in 902 KAR 100:050;

††††† (e) Furnish the following to either the
cabinet, U.S. Nuclear Regulatory Commission, or agreement state:

††††† 1. A report of each transfer of an
industrial product or device to a person for use pursuant to the general
license in 902 KAR 100:050. The report shall identify:

††††† a. A general licensee by name and
address;

††††† b. An individual, by name or position,
who constitutes a point of contact between the cabinet and the general
licensee;

††††† c. The type and model number of device
transferred; and

††††† d. The quantity of depleted uranium
contained in the product or device.

††††† 2. The report identified in subparagraph
1 of this paragraph shall be submitted within thirty (30) days after the end of
a calendar quarter in which the product or device is transferred to the
generally licensed person. If no transfers have been made to persons generally
licensed pursuant to 902 KAR 100:050 during the reporting period, the report
shall so indicate; and

††††† (f) Keep records showing the name,
address, and point of contact for a general licensee to whom he transfers
depleted uranium in an industrial product or device for use authorized by the
general license provided in 902 KAR 100:050 or equivalent regulations of the
U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be
maintained for a period of three (3) years from the date of transfer and shall
show the date of each transfer, the quantity of depleted uranium in a product
or device transferred, and compliance with the report requirements of this
section.

††††† Section 12. Licensing the Distribution of
Naturally Occurring and Accelerator Produced Radioactive Material (NARM) in
Exempt Quantities. (1) An application for a specific license to distribute NARM
to persons exempted from these regulations authorized by 902 KAR 100:045 shall
be approved if:

††††† (a) The radioactive material is not
contained in a food, beverage, cosmetic, drug, or other commodity designed for
ingestion or inhalation by, or application to, a human being;

††††† (b) The radioactive material is in the
form of processed chemical elements, compounds, or mixtures, tissue samples,
bioassay samples, counting standards, plated or encapsulated sources, or
similar substances, identified as radioactive and to be used for its radioactive
properties, but is not incorporated into a manufactured or assembled commodity,
product, or device intended for commercial distribution; and

††††† (c) The applicant submits copies of
prototype labels and brochures in accordance with 10 C.F.R. 32.18 and 32.19 and
the cabinet approves the labels and brochures.

††††† (2) The license issued pursuant to this
section shall be subject to the following conditions:

††††† (a) More than ten (10) exempt quantities
shall not be sold or transferred in a single transaction. However, an exempt
quantity may be composed of fractional parts of one (1) or more of the exempt
quantity, if the sum of the fractions does not exceed unity.

††††† (b) An exempt quantity shall be packaged
separately and individually. More than ten (10) packaged exempt quantities
shall not be contained in an outer package for transfer to persons exempt as
authorized by 902 KAR 100:045. The dose rate at the external surface of the
outer package shall not exceed five-tenths (0.5) millirem per hour.

††††† 1. Identifies the radionuclide and the
quantity of radioactivity; and

††††† 2. Bears the words "Radioactive Material."

††††† (d) In addition to the labeling
information required by this subsection, the label affixed to the immediate
container, or an accompanying brochure, shall:

††††† 1. State that the contents are exempt
from licensing agency requirements;

††††† 2. Bear the words "Radioactive
Material - Not for Human Use - Introduction into Foods, Beverages, Cosmetics,
Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution
is Prohibited - Exempt Quantities Should Not Be Combined"; and

††††† (3)(a) A person licensed pursuant to this
section shall maintain records identifying, by name and address, each person to
whom radioactive material is transferred for use in accordance with 902 KAR
100:045 or the equivalent regulations of a licensing agency, and stating the
kinds and quantities of radioactive material transferred.

††††† (b) An annual summary report stating the
total quantity of each radionuclide transferred under the specific license
shall be filed with the cabinet.

††††† (c) A report shall cover the year ending
June 30 and shall be filed within thirty (30) days after June 30. The report
shall indicate if no transfers of radioactive material have been made during
the reporting period, as authorized by this section.

††††† Section 13. Licensing the Incorporation
of Naturally Occurring and Accelerator Produced Radioactive Material (NARM) into
Gas and Aerosol Detectors. (1) An application for a specific license authorizing
the incorporation of NARM into gas and aerosol detectors to be distributed to
persons exempt pursuant to 902 KAR 100:045 shall be approved if the application
satisfies requirements equivalent to those contained in U.S. Nuclear Regulatory
Commission 10 C.F.R. Part 32.26.